Medical approval House Bill 810 passed in Texas for Parkinson's! What is the Federal level going to do!

People We have a voice!

HB 810 was passed by our Governor in Texas! Now this is on a federal level! Could it be years before approval based on the Federal Government or could this be passed in June of 2018?! The drafting of this law is forthcoming!  See below contact information and please consider signing this petition as well.  Please read below:

House Bill 810/ Parkinson's and other needs

A fee is charged of 2.4 Million for the approval of a drug manufacturer to release the latest medication on the market for what ever medical condition you have!

Is there a cap limit on what the manufacturer can charge for the release of the name brand drug the answer is NO!!! 

My Mother has Parkinson's and the physician told us do not worry Parkinson's will not kill her.

It is the medication that will KILL Her as it is toxic! Medications for this condition are very limited.

I ask for your support to this petition.

The Pharma food chain goes up the corporate level as does the cost.

I believe Stem Cell is a wonderful option from the reviews and physicians sharing favorable results.

Stem Cell therapy in now an option for certain types of cancer, even for the knee's and potentially for the back.

Humans should have a choice!  I ask our FDA and Insurance companies to cover this as an option!  It is less invasive as you use your own stem cells!  Below is the FDA information and protocol. 

The Government incorporated HIPPA Laws for privacy!  Perhaps all Physicians should have a form called a checklist and be compensated by the insurance agency for this review and sign off like the HIPPA forms??!! The reason I say this as I looked up on line through the FDA the side effects and I was overwhelmed!

I do understand it is printed when picked up at a pharmacy in fine little print.  Do you believe The Human race reads this as a rule?

Is this Human Race in a process of Elimination?

Our seniors may need Magnify glasses or some type of Reading glasses to see the side effects. 

Insurance has hit rock bottom toilet levels. 

A physician's oath is do no harm! Physicians worked for their degree and earned it!

I know the physicians have been less compensated for the work they put into serving their patients. Negotiations on contracts between insurance companies and providers are distorted.

Controlled by Greed, Government Policies, and Insurance companies and Big Pharma!

You can make a complaint through the FDA as a form is online.

Hopefully new options are on the Horizon! In the State of Texas HB-810 was signed off on.  It is now in Federal review.

 I believe money can be the driving force and even takes the lives of our loved ones to soon!

 I pray for the manufacturers .  When phoned for coupons or discounts through the FDA they have a recording stating to phone each manufacturer for each drug.

I do understand it takes money for scientist and biochemist for create new medications.

My hope is when you have been gifted in your journey of life may if be used serving the higher and greater than yourself!!!!!!

Yes, we reside in New Braunfels and are Business owners.  Would I insure what is out there for all concerned regarding health Insurance NO!  I am a Insurance agent that has been self-employed 30 years in this business.

My Mother's page is https://www.gofundme.com/beverlys-medical-fund-stemcell

The following information is publicly available from the FDA:

Thank you for your telephone inquiry to the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) regarding stem cell therapy. CBER, one of seven centers within FDA, is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products. We hope the following information will be helpful.

At this time, FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications. These specific indications do not include use for the treatment of Parkinson's disease. As such, we will be unable to provide information on unapproved stem cell treatments. Federal law (21 CFR 601.50 and 21 CFR 601.51) prohibits FDA from disclosing, or even acknowledging any information regarding unapproved products. While Federal regulations prohibit FDA from discussing specific investigational therapies, we can certainly provide you with information on how FDA regulates stem cells.

FDA is responsible for regulating stem cell therapies and ensuring the safety and efficacy of these biological products in the United States. It is the responsibility of a manufacturer or sponsor to develop a product and conduct studies sufficient to demonstrate the product's safety and efficacy. FDA uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for regulatory oversight of stem cell therapies. Stem cells, regardless of origin, have the remarkable potential to develop into many different cell types in the body. However, there is still much to learn about how cellular products work, how to administer them safely, and whether, over time, the cells will continue to work properly in the body without harmful side effects, whether they are autologous stem cells (from one's own body) or from a donor.

Stem cells and other cellular and tissue products are regulated as Human Cells, Tissue, and Cellular and Tissue-based Products (HCT/Ps). The regulations in 21 CFR Part 1271 identify the criteria for regulation solely under Section 361 of the Public Health Service (PHS) Act. Section 361 focuses on preventing transmission of communicable disease. If all of the criteria in 21 CFR Section 1271.10 are met then no pre-market review (application to FDA) is required. To satisfy these criteria, an HCT/P must be:

No more than minimally manipulated (relates to the nature and degree of processing);

intended for homologous use only (the product performs the same basic function in the donor as in the recipient);

not combined with another article (with some limited exceptions); and

the HCT/P does not have a systemic effect and is not dependent on the metabolic activity of living cells for its primary function, or if it does, the HCT/P is intended for autologous use or use by a first- or second-degree blood relative.

HCT/Ps that do not meet all of the criteria of 21 CFR Section 1271.10 are also regulated under Section 351 of the PHS Act and/or the Federal Food, Drug and Cosmetic Act as drugs, devices and/or biological products and would require premarket approval, or be the subject of a clinical study conducted under an Investigational New Drug Application (IND).

All currently licensed cellular therapy products can be found on our website at the following link: http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/default.htm

Information on cellular and gene therapy is available on the FDA website at: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm

Cellular and gene therapy guidances are available at:

https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/default.htm

There are several mechanisms by which patients can obtain access to investigational new drugs (INDs), which are not yet approved by FDA. The first method is through clinical trials. Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. While FDA cannot recommend specific clinical trials, patients can visit http://www.clinicaltrials.gov/ to search for relevant clinical trials. ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. The site provides information about a trial's purpose, who may participate, locations, and phone numbers for more details. You can contact one or more of the sponsors directly for additional information. Please bear in mind, the information provided on ClinicalTrials.gov should be used in conjunction with advice from health care professionals.

Information about clinical trials for which the National Institutes of Health (NIH) is recruiting across the U.S. and Canada can be found at:

https://www.ninds.nih.gov/Disorders/all-disorders

https://www.nih.gov/health-information/nih-clinical-research-trials-you/finding-clinical-trial

Also, the International Society for Stem Cell Research (ISSCR) provides useful information about stem cell treatments (http://www.isscr.org).

Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials. The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. FDA is able to authorize emergency use of a biologic or drug product under certain conditions. This is called an Emergency or Individual Patient IND. For additional information on access to investigational drugs, please visit our website at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm.

Information on a physician request for an individual patient IND under expanded access for non-emergency or emergency use is available on the FDA website at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm.

FDA encourages consumers to learn all they can about the regulations covering any stem cell-based product they are considering and has posted a Consumer Update entitled, "FDA Warns About Stem Cell Claims" (https://www.fda.gov/forconsumers/consumerupdates/ucm286155.htm) to educate and advise consumers about unproven and potentially unsafe stem cell therapies. Individuals considering stem cell therapy are urged to ask questions to ensure that the necessary FDA approval has been obtained or that they will be part of an FDA-regulated clinical study conducted under an active investigational new drug application on file with the FDA.

There is also a recent statement from the Commissioner that addresses stem cell clinics and regenerative medicine as a whole: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm .

We recognize the importance of the development of novel and promising new therapies for serious diseases for which current treatment is unsatisfactory. Although, the Agency cannot provide a definitive timeline for approval of these new therapies, FDA scientists are committed to continuing to work closely with all sponsors developing promising new therapies in order to help meet serious unmet medical needs.

We hope this information is helpful. If you have questions, please feel free to contact us at ocod@fda.hhs.gov or by phone at 1-800-835-4709.